Solid Tumor
Conditions
Brief summary
A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors
Interventions
DRUGHLX 208
take orally
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18Y≤Age≤75Y * Good Organ Function * Expected survival time ≥ 3 months * Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment * Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage. * ECOG score 0-1; * Expected survival time of more than 3 months;
Exclusion criteria
* Previous treatment with BRAF inhibitors or MEK inhibitors * Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable). * Current or former patients with interstitial lung disease; * Active clinical severe infection; * A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin. * Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD | from first dose to the end of Cycle 1 (each cycle is 21 days) | maximum tolerated dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of HLX208 | from first dose to the beginning of Cycle 4 (each cycle is 21 days) | pharmacokinetics |
| RP2D | from first dose to the end of Cycle 1 (each cycle is 21 days) | Recommended dose for phase II clinical trials |
| ORR | from first dose to the last patient was followed up for 6 month | The number of patients with CR or PR divided by the total number of treated patients whose disease was measurable at baseline |
| Area under the plasma concentration versus time curve (AUC)of HLX208 | from first dose to the beginning of Cycle 4 (each cycle is 21 days) | pharmacokinetics |
Countries
China
Contacts
Primary ContactZhang Li, leading PI
Backup ContactGuo ye, PI
Outcome results
None listed